Out-of-office Monitoring for Rhythms Of Normal Versus Atrial Fibrillation (OMRON-AF)

May 6, 2026 updated by: University of California, San Francisco

The goal of this clinical trial is to learn if screening for atrial fibrillation (AFib), a common irregular heart rhythm, through daily home blood pressure monitoring will decrease the time to atrial fibrillation diagnosis in older adults with hypertension. The main question it aims to answer is:

-- Does introducing screening for AFib using a blood pressure monitor with AFib detection technology decrease time to AFib diagnosis in patients with high blood pressure, compared to usual care using a conventional home blood pressure monitor with no AFib detection?

Participants will participate in two phases of the study: (1) clinical trial and (2) the registry.

During the 6-month clinical trial period, participants will be asked to:

  • Take blood pressure measurements twice daily
  • Answer short weekly mobile app-based surveys
  • If assigned, complete continuous heart monitoring for 2 weeks and complete 1 blood test

During the 12-month registry period, participants will be asked to:

  • Take blood pressure measurements twice daily
  • Answer monthly mobile app-based surveys

Researchers will compare standard blood pressure measurements and AFib screening blood pressure measurements to see if there is a difference in the time to AFib diagnosis and other cardiovascular events.

Participants will participate in two phases of the study: (1) trial and (2) the registry.

During the 6-month trial period, participants will be asked to:

  • Take daily blood pressure measurements
  • Answer short weekly mobile app-based surveys
  • If assigned, complete continuous heart monitoring for 2 weeks and complete 1 blood test

During the 12-month registry period, participants will be asked to:

  • Take daily blood pressure measurements
  • Answer monthly mobile app-based surveys

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This prospective, randomized controlled trial and registry aims to compare the diagnosis rate of Atrial Fibrillation (AFib) in participants with high blood pressure (BP) using either (1) a BP monitor with AFib detection technology or (2) a conventional BP monitor without AFib detection technology. Eligible participants are those who are English speaking individuals with a mailing address in the contiguous U.S., over the age of 60 with high blood pressure and meet one or more of the following:

  • 70 years old or older
  • BMI of 30 kg/m2 or greater -- CHA2DS2-VASc greater than or equal to 3 (excluding Female sex)

For the first 6 months, participants will be randomly assigned to use one of two blood pressure monitors, one with AFib detection (intervention group) or one without (control group). Those randomly assigned to the AFib detection BP monitor will be asked to answer short weekly mobile app-based surveys and take daily blood pressure measurements using their assigned device (4 daily measurements, 2 in the morning and 2 at night). During the first 6 months only, if an intervention group participant is notified by their device that potential AFib has been detected, they will be asked to wear a continuous ECG recording device for 2 weeks and to complete a blood test measuring NT-proBNP levels. Those randomly assigned to the BP monitor without AFib detection will be asked to answer short weekly mobile app-based surveys and take daily blood pressure measurements using their assigned device (4 daily measurements, 2 in the morning and 2 at night). During the first 6 months only, control group participants in this group may be randomly assigned to wear a continuous ECG recording device for 2 weeks and to complete a blood test measuring NT-proBNP levels. An equal number from both groups will be selected.

Following the first 6 months, participants will enter a 12-month 'Registry' phase. Participants in the control arm will receive a BP cuff with AFib detection technology. All participants will be asked to take daily measurements (4 daily, 2 in the morning and 2 at night) using the BP monitor with AFib detection and answer monthly mobile-app surveys. These surveys will be used to assess cardiovascular related events and any AFib occurrence. Some participants may be contacted for additional information. About 1,910 participants will be enrolled in this study.

Study Type

Interventional

Enrollment (Estimated)

1910

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF Medical Center at Parnassus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Hypertensive* patients aged 60 years or older living in the United States who meet at least one of the following criteria:

  • ≥70 years old
  • BMI ≥30kg/m2
  • CHA2DS2-VASc ≥3 (excluding Female sex)

Exclusion Criteria:

  • Current or prior diagnosis of atrial fibrillation (AFib), atrial flutter, or atrial tachycardia
  • Receiving anticoagulation therapy
  • History of skin allergies to adhesive patches
  • Open wound or skin inflammation, such as eczema, in the chest region.
  • Inability to wear the patch ECG monitor or apply the monitor by herself/himself or with the help of a caregiver
  • Individuals who are currently using home medical devices or wearable devices capable of detecting atrial fibrillation and are unwilling to refrain from using such AF detection device features during the randomized controlled trial (RCT) phase of the study
  • People who have a mailing address in Alaska, Hawaii, or a U.S. territory

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard Blood Pressure Monitoring (No AFib Detection)
Participants in this arm will be assigned to take twice-daily blood pressure measurements using the OMRON Silver Upper Arm Blood Pressure Monitor (BP5255) with no AFib detection features for the first 6 months of study participation. During the 12-month registry, all participants will be asked to use the OMRON 7 Series Upper Arm Blood Pressure Monitor (BP7360) for their twice-daily measurements.
Device: Blood Pressure Monitor Without AFib Detection
Participants with this intervention will be assigned to take twice-daily blood pressure measurements using the OMRON Silver Upper Arm Blood Pressure Monitor (BP5255) with no AFib detection features for the first 6 months of study participation. During the 12-month registry, all participants will be asked to use the 7 Series Upper Arm Blood Pressure Monitor (BP7360) for their twice-daily measurements.
Other Names:
  • BP5255
  • OMRON Silver Upper Arm Blood Pressure Monitor
Experimental: Intervention Blood Pressure Monitoring (AFib Detection)
Participants in this arm will be assigned to take twice-daily blood pressure measurements using the OMRON 7 Series Upper Arm Blood Pressure Monitor (BP7360) with AFib detection features for all 18 months of study participation.
Device: Blood Pressure Monitor With AFib Detection
Participants with this intervention will be assigned to take twice daily blood pressure measurements using the OMRON 7 Series Upper Arm Blood Pressure Monitor (BP7360) with AFib detection features for all 18 months of study participation.
Other Names:
  • BP7360
  • OMRON 7 Series Upper Arm Blood Pressure Monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first AFib diagnosis within 6 months after randomization
Time Frame: Throughout and up to 6-months post randomization
The primary outcome will be time to AFib diagnosis, defined as the earliest AFib confirmed on a study continuously-recording ECG patch, or AFib clinically diagnosed during usual care (recorded by a treating clinician in the medical record, independent of study ECG patch confirmation).
Throughout and up to 6-months post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Yield of a Continuous ECG Monitor
Time Frame: Throughout and up to 6-months post randomization
A secondary outcome will be the diagnostic yield of high NT-proBNP detected by a blood test completed during a participant's first 6 months of participation, either for the study or during usual clinical care.
Throughout and up to 6-months post randomization
Diagnostic Yield of High NT-proBNP Cases in Blood Tests
Time Frame: Throughout and up to 6-months post randomization
A secondary outcome will be the diagnostic yield of high NT-proBNP detected by a blood test completed during a participant's first 6 months of participation, either for the study or during usual clinical care.
Throughout and up to 6-months post randomization
Time to First Occurrence of a 6-component Composite Event
Time Frame: Throughout 18-month study enrollment
Throughout the course of the 18-months of participation, participants will answer mobile-app based surveys regarding occurrence of cardiovascular health events including (1) ischemic stroke/TIA, (2) myocardial infarction [MI], (3) noncentral nervous system [CNS] embolism or thrombosis, (4) hospitalization or emergency department visit for HF, (5) cardiovascular hospitalization or (6) all-cause mortality. A secondary outcome will be a comparison of the time to the first occurrence of these cardiovascular health-related events between individuals who detected AFib by a continuous ECG monitor or by Pressure Pulse Wave (PPW) blood pressure monitor (with AFib detection) and those who did not.
Throughout 18-month study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Omron Healthcare Co., Ltd.

Investigators

  • Principal Investigator: Gregory M Marcus, MD, MAS, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

May 4, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-45123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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